Hytrin
- Generic Name: terazosin hcl
- Brand Name: Hytrin
- Drug Class: Alpha Blockers, Antihypertensives
Hytrin (Terazosin Hcl) side effects drug center
Hytrin Side Effects Center
What Is Hytrin?
Hytrin (terazosin hydrochloride) is an alpha-adrenergic blocker used to treat hypertension (high blood pressure) and benign prostatic hyperplasia (enlarged prostate). Hytrin is available in generic form.
What Are Side Effects of Hytrin?
Common side effects of Hytrin include:
- fatigue,
- nausea,
- weakness,
- drowsiness,
- blurred vision,
- headache,
- stuffy nose,
- difficulty breathing, or
- impotence.
- Lightheadedness or dizziness upon standing may also occur, especially after the first dose of Hytrin, and shortly after taking the drug during the first week of treatment.
Tell your doctor if you have any serious side effects of Hytrin including:
- fainting,
- fast or irregular heartbeat,
- burning or tingling in the hands or feet,
- sexual function problems,
- swelling of the ankles/hands/feet, or
- unexpected weight gain.
Dosage for Hytrin
To treat benign prostatic hyperplasia, the starting dose of Hytrin is 1 mg at bedtime, with dosage gradually increased to 10 mg. To treat hypertension, the starting dose is 1 mg at bedtime. The usual recommended dose range is 1 mg to 5 mg administered once a day; some patients benefit from doses as high as 20 mg per day.
What Drugs, Substances, or Supplements Interact with Hytrin?
Hytrin may interact with sildenafil, tadalafil, vardenafil, or other blood pressure medications.
Hytrin During Pregnancy and Breastfeeding
Tell your doctor all medications you use. Hytrin should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Hytrin (terazosin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Hytrin Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast or pounding heartbeats or fluttering in your chest;
- a light-headed feeling, like you might pass out;
- swelling in your hands, ankles, or feet; or
- penis erection that is painful or lasts 4 hours or longer.
Common side effects may include:
- weakness;
- dizziness, drowsiness;
- stuffy or runny nose; or
- swelling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Hytrin (Terazosin Hcl)
Hytrin Professional Information
SIDE EFFECTS
Benign Prostatic Hyperplasia
The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1% and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.
Table 1. Adverse Reactions During Placebo-controlled Trials
Benign Prostatic Hyperplasia
| Body System | Terazosin (N = 636) |
Placebo (N = 360) |
| BODY AS A WHOLE | ||
| †Asthenia | 7.4%* | 3.3% |
| Flu Syndrome | 2.4% | 1.7% |
| Headache | 4.9% | 5.8% |
| CARDIOVASCULAR SYSTEM | ||
| Hypotension | 0.6% | 0.6% |
| Palpitations | 0.9% | 1.1% |
| Postural Hypotension | 3.9%* | 0.8% |
| Syncope | 0.6% | 0.0% |
| DIGESTIVE SYSTEM | ||
| Nausea | 1.7% | 1.1% |
| METABOLIC AND NUTRITIONAL DISORDERS | ||
| Peripheral Edema | 0.9% | 0.3% |
| Weight Gain | 0.5% | 0.0% |
| NERVOUS SYSTEM | ||
| Dizziness | 9.1%* | 4.2% |
| Somnolence | 3.6%* | 1.9% |
| Vertigo | 1.4% | 0.3% |
| RESPIRATORY SYSTEM | ||
| Dyspnea | 1.7% | 0.8% |
| Nasal Congestion/Rhinitis | 1.9%* | 0.0% |
| SPECIAL SENSES | ||
| Blurred Vision/Amblyopia | 1.3% | 0.6% |
| UROGENITAL SYSTEM | ||
| Impotence | 1.6%* | 0.6% |
| Urinary Tract Infection | 1.3% | 3.9%* |
| † Includes weakness, tiredness, lassitude and fatigue. * p ≤ 0.05 comparison between groups. |
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Additional adverse events have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin. The safety profile of patients treated in the long-term open-label study was similar to that observed in the controlled studies.
The adverse events were usually transient and mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In the placebo-controlled clinical trials, the rates of premature termination due to adverse events were not statistically different between the placebo and terazosin groups. The adverse events that were bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 2.
Table 2. Discontinuation During Placebo-controlled Trials
Benign Prostatic Hyperplasia
| Body System | Terazosin (N = 636) |
Placebo (N = 360) |
| BODY AS A WHOLE | ||
| Fever | 0.5% | 0.0% |
| Headache | 1.1% | 0.8% |
| CARDIOVASCULAR SYSTEM | ||
| Postural Hypotension | 0.5% | 0.0% |
| Syncope | 0.5% | 0.0% |
| DIGESTIVE SYSTEM | ||
| Nausea | 0.5% | 0.3% |
| NERVOUS SYSTEM | ||
| Dizziness | 2.0% | 1.1% |
| Vertigo | 0.5% | 0.0% |
| RESPIRATORY SYSTEM | ||
| Dyspnea | 0.5% | 0.3% |
| SPECIAL SENSES | ||
| Blurred Vision/Amblyopia | 0.6% | 0.0% |
| UROGENITAL SYSTEM | ||
| Urinary Tract Infection | 0.5% | 0.3% |
Hypertension
The prevalence of adverse reactions has been ascertained from clinical trials conducted primarily in the United States. All adverse experiences (events) reported during these trials were recorded as adverse reactions. The prevalence rates presented below are based on combined data from fourteen placebo-controlled trials involving once-a-day administration of terazosin, as monotherapy or in combination with other antihypertensive agents, at doses ranging from 1 to 40 mg. Table 3 summarizes those adverse experiences reported for patients in these trials where the prevalence rate in the terazosin group was at least 5%, where the prevalence rate for the terazosin group was at least 2% and was greater than the prevalence rate for the placebo group, or where the reaction is of particular interest. Asthenia, blurred vision, dizziness, nasal congestion, nausea, peripheral edema, palpitations and somnolence were the only symptoms that were significantly (p < 0.05) more common in patients receiving terazosin than in patients receiving placebo. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials.
Table 3. Adverse Reactions During Placebo-controlled Trials
Hypertension
| Body System | Terazosin (N = 859) |
Placebo (N = 506) |
| BODY AS A WHOLE | ||
| †Asthenia | 11.3%* | 4.3% |
| Back Pain | 2.4% | 1.2% |
| Headache | 16.2% | 15.8% |
| CARDIOVASCULAR SYSTEM | ||
| Palpitations | 4.3%* | 1.2% |
| Postural Hypotension | 1.3% | 0.4% |
| Tachycardia | 1.9% | 1.2% |
| DIGESTIVE SYSTEM | ||
| Nausea | 4.4%* | 1.4% |
| METABOLIC AND NUTRITIONAL DISORDERS | ||
| Edema | 0.9% | 0.6% |
| Peripheral Edema | 5.5%* | 2.4% |
| Weight Gain | 0.5% | 0.2% |
| MUSCULOSKELETAL SYSTEM | ||
| Pain-Extremities | 3.5% | 3.0% |
| NERVOUS SYSTEM | ||
| Depression | 0.3% | 0.2% |
| Dizziness | 19.3%* | 7.5% |
| Libido Decreased | 0.6% | 0.2% |
| Nervousness | 2.3% | 1.8% |
| Paresthesia | 2.9% | 1.4% |
| Somnolence | 5.4%* | 2.6% |
| RESPIRATORY SYSTEM | ||
| Dyspnea | 3.1% | 2.4% |
| Nasal Congestion | 5.9%* | 3.4% |
| Sinusitis | 2.6% | 1.4% |
| SPECIAL SENSES | ||
| Blurred Vision | 1.6%* | 0.0% |
| UROGENITAL SYSTEM | ||
| Impotence | 1.2% | 1.4% |
| † Includes weakness, tiredness, lassitude and fatigue. * Statistically significant at p = 0.05 level. |
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Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin. The following additional adverse reactions were reported by at least 1% of 1987 patients who received terazosin in controlled or open, short- or long-term clinical trials or have been reported during marketing experience:
Body as a Whole
chest pain, facial edema, fever, abdominal pain, neck pain, shoulder pain
Cardiovascular System
Digestive System
constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting
Metabolic/Nutritional Disorders
Musculoskeletal System
arthralgia, arthritis, joint disorder, myalgia
Nervous System
Respiratory System
bronchitis, cold symptoms, epistaxis, flu symptoms, increased cough, pharyngitis, rhinitis
Skin and Appendages
Special Senses
abnormal vision, conjunctivitis, tinnitus
Urogenital System
urinary frequency, urinary incontinence primarily reported in postmenopausal women, urinary tract infection.
The adverse reactions were usually mild or moderate in intensity but sometimes were serious enough to interrupt treatment. The adverse reactions that were most bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 4.
Table 4. Discontinuations During Placebo-controlled Trials
Hypertension
| Body System | Terazosin (N = 859) |
Placebo (N = 506) |
| BODY AS A WHOLE | ||
| Asthenia | 1.6% | 0.0% |
| Headache | 1.3% | 1.0% |
| CARDIOVASCULAR SYSTEM | ||
| Palpitations | 1.4% | 0.2% |
| Postural Hypotension | 0.5% | 0.0% |
| Syncope | 0.5% | 0.2% |
| Tachycardia | 0.6% | 0.0% |
| DIGESTIVE SYSTEM | ||
| Nausea | 0.8% | 0.0% |
| METABOLIC AND NUTRITIONAL DISORDERS | ||
| Peripheral Edema | 0.6% | 0.0% |
| NERVOUS SYSTEM | ||
| Dizziness | 3.1% | 0.4% |
| Paresthesia | 0.8% | 0.2% |
| Somnolence | 0.6% | 0.2% |
| RESPIRATORY SYSTEM | ||
| Dyspnea | 0.9% | 0.6% |
| Nasal Congestion | 0.6% | 0.0% |
Post-marketing Experience
Post-marketing experience indicates that in rare instances patients may develop allergic reactions, including anaphylaxis, following administration of terazosin hydrochloride. There have been reports of priapism and thrombocytopenia during post-marketing surveillance. Atrial fibrillation has been reported.
During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy (see PRECAUTIONS).
Read the entire FDA prescribing information for Hytrin (Terazosin Hcl)
&Copy; Hytrin Patient Information is supplied by Cerner Multum, Inc. and Hytrin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.